GrippeEspagneV1, Main, Exploration, bibRecord, 000086

The STOP-AB trial protocol: efficacy and safety of discontinuing patient antibiotic treatment when physicians no longer consider it necessary.

Identifieur interne : 000086 ( Main/Exploration ); précédent : 000085; suivant : 000087

The STOP-AB trial protocol: efficacy and safety of discontinuing patient antibiotic treatment when physicians no longer consider it necessary.

Auteurs : Carl Llor [Espagne] ; Ana Moragas [Espagne] ; Carolina Bayona [Espagne] ; Josep M. Cots [Espagne] ; José M. Molero [Espagne] ; Joana Ribas [Espagne] ; Julio Francisco F Thy [Espagne] ; Isabel Gutiérrez [Espagne] ; Coro Sánchez [Espagne] ; Jesús Ortega [Espagne] ; Javier Arranz [Espagne] ; Jenifer Botanes [Espagne] ; Purificaci N Robles [Espagne]

Source :

BMJ open [ 2044-6055 ] ; 2017.

RBID : pubmed:28592581

Descripteurs français

KwdFr :
- Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Antibactériens (administration et posologie), Antibactériens (effets indésirables), Calendrier d'administration des médicaments (MeSH), Espagne (MeSH), Femelle (MeSH), Humains (MeSH), Indice de gravité de la maladie (MeSH), Infections de l'appareil respiratoire (microbiologie), Infections de l'appareil respiratoire (traitement médicamenteux), Jeune adulte (MeSH), Maladies virales (complications), Modèles linéaires (MeSH), Mâle (MeSH), Plan de recherche (MeSH), Résultat thérapeutique (MeSH), Satisfaction des patients (statistiques et données numériques), Soins de santé primaires (statistiques et données numériques), Sujet âgé (MeSH).
MESH :
- administration et posologie : Antibactériens.
- effets indésirables : Antibactériens, Maladies virales.
- microbiologie : Infections de l'appareil respiratoire.
- statistiques et données numériques : Satisfaction des patients, Soins de santé primaires.
- traitement médicamenteux : Infections de l'appareil respiratoire.
- Adolescent, Adulte, Adulte d'âge moyen, Calendrier d'administration des médicaments, Espagne, Femelle, Humains, Indice de gravité de la maladie, Jeune adulte, Modèles linéaires, Mâle, Plan de recherche, Résultat thérapeutique, Sujet âgé.

English descriptors

KwdEn :
- Adolescent (MeSH), Adult (MeSH), Aged (MeSH), Anti-Bacterial Agents (administration & dosage), Anti-Bacterial Agents (adverse effects), Drug Administration Schedule (MeSH), Female (MeSH), Humans (MeSH), Linear Models (MeSH), Male (MeSH), Middle Aged (MeSH), Patient Satisfaction (statistics & numerical data), Primary Health Care (statistics & numerical data), Research Design (MeSH), Respiratory Tract Infections (drug therapy), Respiratory Tract Infections (microbiology), Severity of Illness Index (MeSH), Spain (MeSH), Treatment Outcome (MeSH), Virus Diseases (complications), Young Adult (MeSH).
MESH :
- chemical , administration & dosage : Anti-Bacterial Agents.
- chemical , adverse effects : Anti-Bacterial Agents.
- complications : Virus Diseases.
- drug therapy : Respiratory Tract Infections.
- microbiology : Respiratory Tract Infections.
- statistics & numerical data : Patient Satisfaction, Primary Health Care.
- Adolescent, Adult, Aged, Drug Administration Schedule, Female, Humans, Linear Models, Male, Middle Aged, Research Design, Severity of Illness Index, Spain, Treatment Outcome, Young Adult.

Abstract

INTRODUCTION

Since 2011, the Spanish Society of Family Medicine has recommended general practitioners (GPs) to ask their patients to stop taking antibiotics when they suspect a viral infection. However, this practice is seldom used because uncertainty about diagnosis, and fear of consequences of discontinuing antibiotic therapy, as well as perceived pressure to continue prescribing antibiotics and potential conflict with patients are more of a concern for GPs than antibiotic resistance. The main objective of this study is to determine whether discontinuation of antibiotic therapy when a GP no longer considers it necessary has any impact on the number of days with severe symptoms.

METHODS AND ANALYSIS

This is a multicentre, open-label, randomised controlled clinical trial. The study was conducted in 10 primary care centres in Spain. We included patients from 18 to 75 years of age with uncomplicated acute respiratory tract infections-acute rhinosinusitis, acute sore throat, influenza or acute bronchitis-who had previously taken any dose of antibiotic for <3 days, which physicians no longer considered necessary. The patients were randomly assigned to the usual strategy of continuing antibiotic treatment or to discontinuing antibiotic therapy. A sample size of 240 patients per group was calculated on the basis of a reduction of 1 day in the duration of severe symptoms being a clinically relevant outcome. The primary outcome was the duration of severe symptoms, that is, symptoms scored 5 or 6 by means of validated symptom diaries. Secondary outcomes included antibiotics taken, adverse events, patient satisfaction and complications within the first 3 months.

ETHICS AND DISSEMINATION

The study was approved by the Ethical Board of

TRIAL REGISTRATION NUMBER

NCT02900820; pre-results.

DOI: 10.1136/bmjopen-2016-015814
PubMed: 28592581
PubMed Central: PMC5726137

Affiliations:

Links toward previous steps (curation, corpus...)

to stream Main, to step Corpus: 00092
to stream Main, to step Curation: 000092

Le document en format XML

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<author><name sortKey="Arranz, Javier" sort="Arranz, Javier" uniqKey="Arranz J" first="Javier" last="Arranz">Javier Arranz</name>
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<front><div type="abstract" xml:lang="en"><p><b>INTRODUCTION</b>
</p>
<p>Since 2011, the Spanish Society of Family Medicine has recommended general practitioners (GPs) to ask their patients to stop taking antibiotics when they suspect a viral infection. However, this practice is seldom used because uncertainty about diagnosis, and fear of consequences of discontinuing antibiotic therapy, as well as perceived pressure to continue prescribing antibiotics and potential conflict with patients are more of a concern for GPs than antibiotic resistance. The main objective of this study is to determine whether discontinuation of antibiotic therapy when a GP no longer considers it necessary has any impact on the number of days with severe symptoms.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>METHODS AND ANALYSIS</b>
</p>
<p>This is a multicentre, open-label, randomised controlled clinical trial. The study was conducted in 10 primary care centres in Spain. We included patients from 18 to 75 years of age with uncomplicated acute respiratory tract infections-acute rhinosinusitis, acute sore throat, influenza or acute bronchitis-who had previously taken any dose of antibiotic for <3 days, which physicians no longer considered necessary. The patients were randomly assigned to the usual strategy of continuing antibiotic treatment or to discontinuing antibiotic therapy. A sample size of 240 patients per group was calculated on the basis of a reduction of 1 day in the duration of severe symptoms being a clinically relevant outcome. The primary outcome was the duration of severe symptoms, that is, symptoms scored 5 or 6 by means of validated symptom diaries. Secondary outcomes included antibiotics taken, adverse events, patient satisfaction and complications within the first 3 months.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>ETHICS AND DISSEMINATION</b>
</p>
<p>The study was approved by the Ethical Board of </p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION NUMBER</b>
</p>
<p>NCT02900820; pre-results.</p>
</div>
</front>
</TEI>
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<DateCompleted><Year>2018</Year>
<Month>04</Month>
<Day>09</Day>
</DateCompleted>
<DateRevised><Year>2019</Year>
<Month>02</Month>
<Day>02</Day>
</DateRevised>
<Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">2044-6055</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>7</Volume>
<Issue>5</Issue>
<PubDate><Year>2017</Year>
<Month>06</Month>
<Day>06</Day>
</PubDate>
</JournalIssue>
<Title>BMJ open</Title>
<ISOAbbreviation>BMJ Open</ISOAbbreviation>
</Journal>
<ArticleTitle>The STOP-AB trial protocol: efficacy and safety of discontinuing patient antibiotic treatment when physicians no longer consider it necessary.</ArticleTitle>
<Pagination><MedlinePgn>e015814</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1136/bmjopen-2016-015814</ELocationID>
<Abstract><AbstractText Label="INTRODUCTION">Since 2011, the Spanish Society of Family Medicine has recommended general practitioners (GPs) to ask their patients to stop taking antibiotics when they suspect a viral infection. However, this practice is seldom used because uncertainty about diagnosis, and fear of consequences of discontinuing antibiotic therapy, as well as perceived pressure to continue prescribing antibiotics and potential conflict with patients are more of a concern for GPs than antibiotic resistance. The main objective of this study is to determine whether discontinuation of antibiotic therapy when a GP no longer considers it necessary has any impact on the number of days with severe symptoms.</AbstractText>
<AbstractText Label="METHODS AND ANALYSIS">This is a multicentre, open-label, randomised controlled clinical trial. The study was conducted in 10 primary care centres in Spain. We included patients from 18 to 75 years of age with uncomplicated acute respiratory tract infections-acute rhinosinusitis, acute sore throat, influenza or acute bronchitis-who had previously taken any dose of antibiotic for <3 days, which physicians no longer considered necessary. The patients were randomly assigned to the usual strategy of continuing antibiotic treatment or to discontinuing antibiotic therapy. A sample size of 240 patients per group was calculated on the basis of a reduction of 1 day in the duration of severe symptoms being a clinically relevant outcome. The primary outcome was the duration of severe symptoms, that is, symptoms scored 5 or 6 by means of validated symptom diaries. Secondary outcomes included antibiotics taken, adverse events, patient satisfaction and complications within the first 3 months.</AbstractText>
<AbstractText Label="ETHICS AND DISSEMINATION">The study was approved by the Ethical Board of <i>Fundació Jordi Gol i Gurina</i>
 (reference number: 16/093). The findings of this trial will bedisseminated through research conferences and peer-reviewed journals.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION NUMBER">NCT02900820; pre-results.</AbstractText>
<CopyrightInformation>© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Llor</LastName>
<ForeName>Carl</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre Barcelona-2B (Via Roma), Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Moragas</LastName>
<ForeName>Ana</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Universitat Rovira i Virgili, Primary Healthcare Centre Jaume I, Tarragona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bayona</LastName>
<ForeName>Carolina</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre La Marina, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Cots</LastName>
<ForeName>Josep M</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Universitat of Barcelona, Primary Healthcare Centre La Marina, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Molero</LastName>
<ForeName>José M</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre San Andrés, Madrid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ribas</LastName>
<ForeName>Joana</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre Hospital Son Llàtzer, Palma, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Fóthy</LastName>
<ForeName>Julio Francisco</ForeName>
<Initials>JF</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre Coll d'en Rabassa, Palma, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gutiérrez</LastName>
<ForeName>Isabel</ForeName>
<Initials>I</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre Rondilla I, Valladolid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sánchez</LastName>
<ForeName>Coro</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Primary Care Centre Virxe da Peregrina, Pontevedra, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ortega</LastName>
<ForeName>Jesús</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre Rincón de Soto, Rincón de Soto, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Arranz</LastName>
<ForeName>Javier</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre Arquitecte Bennàssar, Palma, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Botanes</LastName>
<ForeName>Jenifer</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Primary Healthcare Centre Cornellà de Llobregat, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Robles</LastName>
<ForeName>Purificación</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Primary Care Centre Can Vidalet, Esplugues de Llobregat, Spain.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT02900820</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2017</Year>
<Month>06</Month>
<Day>06</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>BMJ Open</MedlineTA>
<NlmUniqueID>101552874</NlmUniqueID>
<ISSNLinking>2044-6055</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000900">Anti-Bacterial Agents</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000900" MajorTopicYN="N">Anti-Bacterial Agents</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016014" MajorTopicYN="N">Linear Models</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017060" MajorTopicYN="N">Patient Satisfaction</DescriptorName>
<QualifierName UI="Q000706" MajorTopicYN="Y">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011320" MajorTopicYN="N">Primary Health Care</DescriptorName>
<QualifierName UI="Q000706" MajorTopicYN="Y">statistics & numerical data</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012107" MajorTopicYN="N">Research Design</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012141" MajorTopicYN="N">Respiratory Tract Infections</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000382" MajorTopicYN="Y">microbiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013030" MajorTopicYN="N">Spain</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014777" MajorTopicYN="N">Virus Diseases</DescriptorName>
<QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
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</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Clinical trials</Keyword>
<Keyword MajorTopicYN="Y">PRIMARY CARE</Keyword>
<Keyword MajorTopicYN="Y">Public health</Keyword>
<Keyword MajorTopicYN="Y">Respiratory infections</Keyword>
</KeywordList>
<CoiStatement>Competing interests: CL reports receiving research grants from the European Commission (Sixth and Seventh Programme Frameworks), Catalan Society of Family Medicine and Instituto de Salud Carlos III (Spanish Ministry of Health).</CoiStatement>
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The STOP-AB trial protocol: efficacy and safety of discontinuing patient antibiotic treatment when physicians no longer consider it necessary.

The STOP-AB trial protocol: efficacy and safety of discontinuing patient antibiotic treatment when physicians no longer consider it necessary.

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